Health TrialsbyHealthPanel

Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients

ConditionsOrthopaedic Related Pain (Musculoskeletal Pain)OpioidPainPilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

This is a single-center, pilot randomized controlled trial designed to evaluate the feasibility of a definitive trial comparing opioid-free discharge prescriptions to usual care (which includes opioids) in patients undergoing major orthopaedic surgery. The main objective is to inform the design and feasibility of the definitive RCT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18 years of age or older

Underwent a major operative orthopaedic procedure

Disqualifiers

Contraindication for NSAIDs.

Preoperative chronic opioid use (preoperative use of >14 days and average of >30 Morphine Milligram Equivalents per day).

Active treatment for opioid use disorder.

Previous or current illicit drug use.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Discharge pain medication prescription

    Other intervention

    The patients in this pilot RCT will either receive a discharge prescription with or without opioids. The specific non-opioid medication (e.g., ibuprofen, paracetamol, ketorolac) determined by the treating physician. The dosage of the prescription including opioids is also determined by the treating physician.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Discharge pain medication prescription without opioidsExperimental treatment 1 intervention
Group B: Usual care discharge prescription (with opioids)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of patient enrollment and treatment allocation

Participant enrollment will be assessed by monitoring screening and enrollment metrics, including: * Participant enrollment * Feasibility of treatment allocation * Data collection methods (Proportion of participants with missing data) * Compliance with the protocol (Proportion of randomization errors, proportion of patients who complete each questionnaire at each of the follow-up, proportion of patients who withdraw from the trial, proportion of participants who are lost to follow-up)

Time frame
From enrollment to the end of the follow-up phase at 6 weeks

Secondary outcomes

1

Opioid Use

Opioid usage assessed at 2 weeks and 6 weeks post-randomization

Time frame
From enrollment to the end of the follow-up at 6 weeks
2

Pain Interference

Pain interference will be assessed using the Brief Pain Inventory at 2 weeks and 6 weeks from randomization.

Time frame
From enrollment to the end of the follow-up at 6 weeks

Other outcomes

Sponsors and contacts

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Massachusetts General Hospital

Lead sponsor

McMaster University

Collaborator

Source ClinicalTrials.gov
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